Endotracheal intubation is a medical procedure used to place an endotracheal tube (artificial airway) into a patient's airway. The endotracheal tube becomes necessary when a patient is unable to maintain a patent airway on their own due to unconsciousness, trauma, disease, drugs or anesthesia. An endotracheal tube may also become necessary when a patient's own respiratory drive is either ineffective or absent due to trauma, disease, drugs or anesthesia, thus requiring mechanical ventilation through the endotracheal tube.
Endotracheal intubation is accomplished by inserting an endotracheal tube into the mouth, through the throat and larynx or voice box, and into the trachea or air passageway which then branches into the bronchial tubes that connect with the lungs. Positioning the endotracheal tube in this manner prevents these natural passageways from collapsing or occluding, thereby permitting respiration air to flow into and out of the lungs. Because a cardiopulmonary arrest may be sustained anywhere, endotracheal tubes must be inserted in out-of-hospital emergency settings by paramedic emergency medical service personnel as well as in hospital settings by emergency department, operating room, and critical care personnel.
It is very important that the endotracheal tube be positioned correctly and maintained in the correct position. If the tube moves out of its proper position in the trachea and into either the right or left mainstem bronchial tube, only one lung will be ventilated. The failure to ventilate the other lung can lead to multiple severe pulmonary difficulties. If the tube moves completely out of its proper position in the trachea and into the esophagus, the patient will become hypoxic due to the lack of ventilation to the lungs, typically resulting in life-threatening brain injury within several minutes.
Even after the endotracheal tube has been positioned correctly, subsequent movement of the patient can lead to inadvertent mal-positioning of the endotracheal tube. Flexion or extension of the patient's neck can apply either a pulling or pushing force on the endotracheal tube, causing the endotracheal tube to move from the trachea into the esophagus or to extend from the trachea into one of the mainstem bronchial tubes, respectively. Such unintentional movement is not uncommon, because the patient frequently needs to be moved, particularly when the patient is moved from an out-of-hospital setting to an emergency department of a hospital. It is sometimes necessary to transfer an intubated patient from one hospital to another hospital, or to move the intubated patient from one area of the hospital to another area in the same hospital. Even repositioning an intubated patient in a hospital bed may cause unintentional movement of the endotracheal tube.
Inadvertent movement of the endotracheal tube may also occur as a result of moving external ventilation equipment, such as a conventional mechanical ventilator or bag valve mask, which is connected to the external end of the endotracheal tube. External ventilation equipment is connected to the endotracheal tube under circumstances where the patient can no longer naturally achieve respiration. Typically, the external ventilation equipment is connected to the external end of the endotracheal tube by an air conduit to establish air flow to and from the lungs through the endotracheal tube. Inadvertent pulling on, or other excessive movement of the air conduit, may transfer movement to the endotracheal tube, thereby moving the endotracheal tube and possibly inadvertently repositioning it from its proper position.
The problem of maintaining the endotracheal tube in the correct position has been recognized and addressed by various prior art devices. Such devices have attempted to secure the endotracheal tube in the proper position and to prevent inadvertent and unintended movement of it. The most common approach for securing the endotracheal tube is tying umbilical tape, which is formed from a cloth material, around the patient's neck and then wrapping and tying the umbilical tape around the smooth outside surface of the endotracheal tube itself. Arranged in this manner, the umbilical tape is intended to anchor the endotracheal tube to the corner of the patient's mouth and prevent its unintentional movement. While the use of the umbilical tape in this manner provides some benefit, the restraint available from the umbilical tape usually diminishes because the tape becomes covered and saturated with blood, saliva, or other bodily fluids, thereby diminishing the frictional restraint of the tape around the endotracheal tube. Consequently, the endotracheal tube is usually able to move from the proper position, even when wrapped with the umbilical tape.
Various auxiliary mechanical securing devices have also been employed to attempt to maintain the endotracheal tube. Many of these auxiliary mechanical devices include some type of faceplate which is attached to the patient's face, usually with one or more straps that extend around the back of the patient's head or neck. The faceplate includes some type of mechanical contact device that grips the endotracheal tube. Typical mechanical contact devices include thumb screws, clamps, adhesives, locking teeth, and straps.
One of the problems with many of these auxiliary mechanical contact devices is that the gripping action becomes less effective when the endotracheal tube becomes wet from bodily fluids, thereby substantially diminishing or eliminating any restraint provided by these devices. To maintain an effective restraint, it is frequently necessary to increase the amount of clamping force applied on the endotracheal tube. Increasing the amount of clamping force to an effective level usually pinches the tube to the point where of the inner tube diameter and hence air passageway is significantly restricted. Restricting the cross-sectional size of the air passageway decreases the ventilatory efficiency of the tube, thereby decreasing the respiratory airflow. The restriction of the cross-sectional size of the air passageway creates resistance to both inspiratory airflow and expiratory airflow. The resistance to inspiration creates either a decreased volume of airflow at a given pressure or an increased pressure to maintain a given airflow. Insufficient airflow can lead to hypoxemia, and increased pressure can lead to barotrauma in the lungs. Resistance to expiratory airflow leads to multiple adverse effects within the lungs. Impairing a patient's ventilations may result in serious medical effects, particularly with patients whose functions are already compromised.
The problem of preventing flexion or extension of the head and neck during endotracheal intubation has been addressed by placing a conventional cervical collar around the neck of the patient. The cervical collar used for this purpose is the typical type used to restrain head and neck movement under circumstances of injury or potential injury to the neck or spinal column. In other words, the cervical collar used during endotracheal intubation is intended to be used for different purpose.